The following data is part of a premarket notification filed by Well Brain International, Ltd. with the FDA for Gymform Abs & Core.
| Device ID | K142055 |
| 510k Number | K142055 |
| Device Name: | GYMFORM ABS & CORE |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | WELL BRAIN INTERNATIONAL, LTD. ROOM 03, 14/F, FOOK YIP BLG., 53-57 KWAI FUNG CRESCENT Kwai Chung, N.t., HK |
| Contact | Victor K Wai |
| Correspondent | Victor K Wai WELL BRAIN INTERNATIONAL, LTD. ROOM 03, 14/F, FOOK YIP BLDG., 53-57 KWAI FUNG CRESCENT Chung, N.t., HK |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-29 |
| Decision Date | 2015-05-11 |
| Summary: | summary |